Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Xellia Acquires Fresenius Kabi’s Manufacturing Plant

Xellia Pharmaceuticals has acquired Fresenius Kabi’s lyophilized vial manufacturing facility in Raleigh, North Carolina. The manufacturing site is Xellia’s first facility in the U.S., expanding the company’s manufacturing capacity for injectable pharmaceutical products. The deal includes a continuous manufacturing and supply agreement with Fresenius Kabi USA.GEN